MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,company represent report with the FDA on 2015-04-08 for QUADROX-I PAD. MIT RESERVOIR 70105.0111 VKMO 30000 manufactured by Maquet Cardiopulmonary Ag.
[16308332]
It was reported that the perfusionist was assembling the circuit and at the time of connecting to the quadrox-i paediatric oxygenator and found that the arterial outlet was completely detached from the oxygenator. The perfusionist has requested to replace the defective on asap no consequences to the pt were reported. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[16471513]
Maquet cardiopulmonary has requested the product in question for eval. A supplemental report will be provided when new info becomes available.
Patient Sequence No: 1, Text Type: N, H10
[69224629]
The manufacturer was informed that the product in question will not be available for evaluation. A review of the device history records (dhr), that were created during the production of the device in question, was performed and no deviations could be found. The product in question met all specifications at the time for final packaging and release. Based on the available information to the manufacturer at this time and without the possibility to evaluate the product in question, a malfunction of the device cannot be confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8010762-2015-00348 |
| MDR Report Key | 4680379 |
| Report Source | 01,05,06,07,COMPANY REPRESENT |
| Date Received | 2015-04-08 |
| Date of Report | 2015-03-10 |
| Date of Event | 2015-03-07 |
| Date Mfgr Received | 2015-11-18 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2015-05-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MICHAEL CAMPBELL |
| Manufacturer Street | KEHLER STRABE 31 |
| Manufacturer City | RASTATT 76437 |
| Manufacturer Country | GM |
| Manufacturer Postal | 76437 |
| Manufacturer Phone | 2229321132 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUADROX-I PAD. MIT RESERVOIR |
| Generic Name | DTN |
| Product Code | DTN |
| Date Received | 2015-04-08 |
| Model Number | 70105.0111 |
| Catalog Number | VKMO 30000 |
| Lot Number | 92115032 |
| Device Expiration Date | 2016-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MAQUET CARDIOPULMONARY AG |
| Manufacturer Address | RASTATT GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-04-08 |